developing a research protocol - duke...
TRANSCRIPT
DEVELOPING A
RESEARCH PROTOCOL
Duke Translational Nursing Institute
bull Describe steps in developing a protocol
bull Describe components of a protocol
bull Discuss when to seek help when
developing a protocol
Objectives
Duke Translational Nursing Institute
What is a Research Protocol
bull A document describing in detail how a research
study is to be conducted in clinical practice
including the methodology a plan for analyzing
the results and a plan to protect human subjects
What Steps Should I Take To
Develop A Research Protocol
Duke Translational Nursing Institute
How to start developing a protocol
bull Follow the IRB guidelines print and read
carefully
bull Keep a list of issues questions
bull Call your IRB rep or study mentor
for clarification of instructions
bull Follow instructions for assembling the protocol
bull eg surveys go in appendices
Duke Translational Nursing Institute
How To Be Efficient When Developing A Protocol
bull Careful planning up front can help avoid possible disasters at the
end - for example ndash Insufficient sample size leads to
Inability to draw a conclusion for a desired patient population
Inability to make assumptions or generalizations about findings
ndash Where will you keep your study data Databases Linking data collection to data forms to databases
Enlist help from experts if necessary
bull Work in one hour blocks of time
bull Use an old protocol as a template
bull Keep the protocol brief
bull Write the first draft without a focus on grammar
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Describe steps in developing a protocol
bull Describe components of a protocol
bull Discuss when to seek help when
developing a protocol
Objectives
Duke Translational Nursing Institute
What is a Research Protocol
bull A document describing in detail how a research
study is to be conducted in clinical practice
including the methodology a plan for analyzing
the results and a plan to protect human subjects
What Steps Should I Take To
Develop A Research Protocol
Duke Translational Nursing Institute
How to start developing a protocol
bull Follow the IRB guidelines print and read
carefully
bull Keep a list of issues questions
bull Call your IRB rep or study mentor
for clarification of instructions
bull Follow instructions for assembling the protocol
bull eg surveys go in appendices
Duke Translational Nursing Institute
How To Be Efficient When Developing A Protocol
bull Careful planning up front can help avoid possible disasters at the
end - for example ndash Insufficient sample size leads to
Inability to draw a conclusion for a desired patient population
Inability to make assumptions or generalizations about findings
ndash Where will you keep your study data Databases Linking data collection to data forms to databases
Enlist help from experts if necessary
bull Work in one hour blocks of time
bull Use an old protocol as a template
bull Keep the protocol brief
bull Write the first draft without a focus on grammar
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
What is a Research Protocol
bull A document describing in detail how a research
study is to be conducted in clinical practice
including the methodology a plan for analyzing
the results and a plan to protect human subjects
What Steps Should I Take To
Develop A Research Protocol
Duke Translational Nursing Institute
How to start developing a protocol
bull Follow the IRB guidelines print and read
carefully
bull Keep a list of issues questions
bull Call your IRB rep or study mentor
for clarification of instructions
bull Follow instructions for assembling the protocol
bull eg surveys go in appendices
Duke Translational Nursing Institute
How To Be Efficient When Developing A Protocol
bull Careful planning up front can help avoid possible disasters at the
end - for example ndash Insufficient sample size leads to
Inability to draw a conclusion for a desired patient population
Inability to make assumptions or generalizations about findings
ndash Where will you keep your study data Databases Linking data collection to data forms to databases
Enlist help from experts if necessary
bull Work in one hour blocks of time
bull Use an old protocol as a template
bull Keep the protocol brief
bull Write the first draft without a focus on grammar
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
What Steps Should I Take To
Develop A Research Protocol
Duke Translational Nursing Institute
How to start developing a protocol
bull Follow the IRB guidelines print and read
carefully
bull Keep a list of issues questions
bull Call your IRB rep or study mentor
for clarification of instructions
bull Follow instructions for assembling the protocol
bull eg surveys go in appendices
Duke Translational Nursing Institute
How To Be Efficient When Developing A Protocol
bull Careful planning up front can help avoid possible disasters at the
end - for example ndash Insufficient sample size leads to
Inability to draw a conclusion for a desired patient population
Inability to make assumptions or generalizations about findings
ndash Where will you keep your study data Databases Linking data collection to data forms to databases
Enlist help from experts if necessary
bull Work in one hour blocks of time
bull Use an old protocol as a template
bull Keep the protocol brief
bull Write the first draft without a focus on grammar
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
How to start developing a protocol
bull Follow the IRB guidelines print and read
carefully
bull Keep a list of issues questions
bull Call your IRB rep or study mentor
for clarification of instructions
bull Follow instructions for assembling the protocol
bull eg surveys go in appendices
Duke Translational Nursing Institute
How To Be Efficient When Developing A Protocol
bull Careful planning up front can help avoid possible disasters at the
end - for example ndash Insufficient sample size leads to
Inability to draw a conclusion for a desired patient population
Inability to make assumptions or generalizations about findings
ndash Where will you keep your study data Databases Linking data collection to data forms to databases
Enlist help from experts if necessary
bull Work in one hour blocks of time
bull Use an old protocol as a template
bull Keep the protocol brief
bull Write the first draft without a focus on grammar
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
How To Be Efficient When Developing A Protocol
bull Careful planning up front can help avoid possible disasters at the
end - for example ndash Insufficient sample size leads to
Inability to draw a conclusion for a desired patient population
Inability to make assumptions or generalizations about findings
ndash Where will you keep your study data Databases Linking data collection to data forms to databases
Enlist help from experts if necessary
bull Work in one hour blocks of time
bull Use an old protocol as a template
bull Keep the protocol brief
bull Write the first draft without a focus on grammar
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
To Write Efficiently Write In The
Following Order
1 Cover sheet ndash title investigators contact information
2 Background of the problem (why do it)
3 Research questions (list specifically)
4 Methods (design setting sample and procedures)
5 Risks HIPAA Informed Consent
6 Review of the literature (write it last)
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
Protocol Development Steps
1 Know what you want to say about the study
question when the study is finished
2 Write a first draft
ndash Start with an outline using a completed protocol
as a template
ndash Do not over-write
3 Break down the protocol into components
ndash Attack one component at a time
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Replicate a study
ndash To evaluate the similarities andor differences in results from the original study
Recreate the study like the original study if the protocol is available
or
Use the manuscript to replicate
the study
Use A Protocol Template to
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Construct a new study
ndash Use any existing protocol as a template
Replicate headings
Borrow wordings construction or layout
Research Summary Instructions available at
DUHS IRB website httpseirbmcdukeedueirbRoomsDisplayPagesLayoutInitialCo
ntainer=comwebridgeentityEntity5BOID5B2374ADAB42020
F4DA3F44AD283EC1EDF5D5D
Use A Protocol Template to
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Keep it simple
bull Use a completed protocol as a template
ndashWrite all components of the protocol as section headings
bull Skip difficult parts ndash Farm out the task later
bull Statistical analysis section
bull Study database
Tips For The First Draft Of A Protocol
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
What Are Components Of A Protocol
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
What Are Required Components for Research
Protocol Submission to IRB
1 Protocol Title
2 Purpose of the Study
3 Background amp Significance
4 Methods - Design amp Procedures
5 Selection of Subjects
6 Subject Recruitment amp Compensation
7 Consent Process ndash see Section 14 of the e-IRB submission form and complete the questions in that section
8 Subjectrsquos Capacity to Give
Legally Effective Consent
9 Study Interventions
10 RiskBenefit Assessment
11 Costs to the Subject
12 Data Analysis amp Statistical
Considerations
13 Data amp Safety Monitoring
14 Privacy Data Storage amp
Confidentiality
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
1 Patient population or research question
2 The approach for the study or the
comparison being made
3 Acronym if possible
What Should the Title Include
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull SUGAR Assessing the SUitability of Capillary
Blood Glucose Analysis in Patients Receiving
Vasopressors
1 Patient population
Patients receiving vasopressors
2 Approach or comparison being made
ldquoAssessing the suitabilityrdquo (descriptive study)
3 Acronym SUGAR
Study Title Example SUGAR
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull DEET Descriptive Evaluation of EKG
Telemetry Pathogens Study
1 Study population
EKG telemetry boxes and electrodes
2 Approach or comparison being made
ldquoDescriptive evaluationrdquo
3 Acronym DEET
Study Title Example DEET
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull FACTS Code Blue Registry Identifying
Factors Associated With In-Hospital
Cardiopulmonary ArresT
1 Study population
Patients with ldquoin-hospital cardiopulmonary arrestrdquo
2 Approach or comparison being made
ldquoIdentifying Factorsrdquo (descriptive study)
3 Acronym FACTs
Study Title Example FACTs
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull The purpose of the study is the broad problem statement
bull For example in DEET study bull Purpose of the study ndash The purpose of this study
is to determine the relationship between surface contaminants on EKG telemetry boxes and lead wires using a new cleaning protocol as compared to standard care in Duke Heart Center cardiovascular progressive care units (7100 7300 3100 and 3300)
What Is the Purpose of the Study
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull The broad problem statement
ndash Important for setting the stage and alerting
the reader to the importance or significance
of the proposed research
ndash Establish the argument or need for doing
the study
bull The information known about the problem is
used for emphasizing the unknown
What Is the Background Information that
Supports the Significance of the Problem
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull In DEET study bull Significant in-patient hospital pathogenic
organisms have impressive lengths of survival on surfaces without adequate cleaninghellip
bull Various patient risk factors for acquiring nosocomial infections have been identified including severity of illness prolonged hospitalization and antecedent antibiotic therapyhellip cross-contamination between patients is an increasingly strong risk factor of hospital-acquired infection
Example of Background Information and the
Significance of the Problem
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Describe how to conduct the study ndash What you intend to do
ndash Population and setting
bull Who When and Where
bull Example in DEET study bull This study will be a prospective cross-sectional controlled intervention
study to evaluate colonization of surface contaminants on telemetry boxes
and lead wires in the Heart Center
bull Medical and surgical adult cardiac patientsrsquo rooms
ndash Medical units71007300 = 32 randomly selected
ndash Surgical units 31003300 = 32 randomly selected
What Is Study Design
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Explain How You Would Collect The Data
bull Describe logistical questions ndash What data to be collected
ndash When and how to collect data
ndash Who
bull Research personnel to perform intervention and data collection
bull Sample population = study participants
bull Describe the exact sequence of events time relationships and individuals involved during the data collection
What Are Study Procedures
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Example in DEET study ndash A sterile swab (single annulet) is opened by the nurse
investigator using clean gloves
ndash The swab will be moistened with sterile water before
swabbing the telemetry box and a wire
ndash Using one swab one swipe of the telemetry box at the
lead connection site and the green EKG lead wire is made
and swab is returned directly to the sterile vial without
making contact with any other site
What Are Study Procedures
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Use supporting literature
ndash Find a description of how the study was set up to answer the question in the ldquoDiscussionrdquo section
bull Recommendations from authors related to design
ndash Design may also be discussed under ldquoLimitationsrdquo in the manuscript
bull If design is not found in reviewed manuscripts
ndash Evaluate your own clinical setting and patient population
ndash Determine what you think will be the best way to go about gathering data to answer your question
ndash Call one or two authors of similar studies and discuss design
bull Ask why a particular design was selected and if the author recommends changes
How To Write Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Variables ldquoA variable is a characteristic measured or observed by information gathering that either varies among the persons events or objects which make up data or is a constantrdquo
bull Independent variables represent the value being manipulated or changed
bull Dependent variables observed result of the independent variable being manipulated
ndash Example in DEET study
bull Independent variables telemetry boxes and lead wires
bull Dependent variables colonization of surface contaminants
When Writing Design Section
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Examine the variables and their relationships
ndash Relationships between the variables are compared
described identified predicted or in some way evaluated to
make a statement at the end of the study to make a statement
ndash Example in SUGAR study
bull The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of
finger stick and arterial blood glucose for each subject
When Writing Design Section
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Description of how subjects will be selected for the study ndash Appropriate number of subjects is based on
bull Type of research design
bull Statistics and significance level
bull Variables being measured
bull Anticipated effect of the study intervention on the dependent variables
ndash Selection of Subjects bull List inclusionexclusion criteria
bull How subjects will be identified
bull Example in SUGAR study ndash The principal nurse investigator or research nurse will identify potential
subjects Fifty adult (age 18 years and above) post-operative cardiothoracic subjects on insulin and vasopressor infusions will be enrolled in the study
What Is ldquoSelection of Subjectsrdquo
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
bull Describe recruitment procedures
ndash Who will introduce the study to potential subjects
ndash Ensure that subject selection is equitable and all relevant
demographic groups have access to study participation (per
45 CFR 46111(a)
bull Define subject compensation if there is to be any
ndash Provide specific prorated amounts to include expenses such
as travel andor lost wages
ndash Provide specific prorated amounts to be provided for
incentive to participate
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Example in SUGAR study ndash The study personnel will recruit all patients meeting
inclusion criteria listed above from a convenience sample of
post-operative cardiothoracic subjects on insulin and
vasopressor infusions on the cardiothoracic intensive care
unit of Duke University Hospital (Unit 3200) The study
subject will receive no form of compensation and no
expense will be incurred as a result of participation our
study
What to Say in ldquoSubject Recruitment amp
Compensationrdquo Section
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Description of how the study consent will be obtained from subjects
bull Example in SUGAR study ndash The patientrsquos care provider will ask permission for participation
in the study Informed consent will then be obtained by the nurse investigator in accordance with the Waiver which states that the nurse investigator will explain the study to the subject or legally authorized representative (LAR) if the patient is temporarily unable to give legally effective consent and will also read through the informed consent with the patient once heshe is capable prior to obtaining signature
What Is a Consenting Process
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Description of who will consent to participate
in the study
bull Example in CHIME study ndash Subjects must have the capacity to give legally effective
consent to be included in this study
What Is ldquoSubject Capacity To Give Legally
Effective Consentrdquo
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Description of research activities that will be done tofor subjects for participating in the study
bull Example in SUGAR study ndash All research activities to be carried out for this protocol are
part of standard clinical practice for patients on insulin infusions and no additional activities exclusively for research purposes will be carried out other than obtaining temporally matched peripheral and arterial samples No investigational drugs or devices are proposed
What Are Study Interventions
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Description of risks and benefits that might incur to subjects due to the study intervention
bull Example in SUGAR study ndash No study related injuries are anticipated If a patient in the study
were injured it would be covered as part of the costs for the typical recovery of a post operative patient since study protocol is consistent with routine care
ndash The potential benefits of participating in this research study will be indirect The knowledge gained from participation in this study may benefit the participants or others who have insulin drips and also require vasopressor infusions
What Is RiskBenefit Assessment
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Description of whether the research will incur
any costs from the subjects
bull Example in SUGAR study ndash No extra monetary cost or compensation to the subject will
be needed as all blood drawnprocedures listed above are
standard practice on in our ICU
What Are Costs to the Subject
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Include preliminary plans for data analysis
bull General ideas about analysis are acceptable ndash May change with the eventual completion of the study
bull Specific idea of the statistical tests that will be used ndash Helpful in considering every piece of data that will be required
for the analysis
bull Example in SUGAR study ndash The data will be analyzed using a one-way repeated-measures
ANOVA This design allows for analysis of multiple correlations of finger stick and arterial blood glucose for each subject
What Are Data Analysis amp Statistical
Considerations
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Describe how the data will be kept safe
bull Example in SUGAR study ndash After recruitment and consent all patient data will be de-
identified by assigning a Study ID number for each patient Patient identifiers will be removed from data collection and stored in a separate password protected database as described below The research plan includes provisions for continuous monitoring of data collection procedures and data storage to ensure the protection of the subject Specifically all patient identifiers will be removed and the data sheets will be kept in a separate locked file that is only accessible to the principle investigator
What Is Data amp Safety Monitoring
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Describe how the data will be kept confidential
bull Example in SUGAR study ndash Research data will be collected and stored on a secured
Microsoft Access database located at a HC network drive The research data will be secured via Username and Password-restricted access to the database in accordance with HIPAA (Health Insurance Portability and Accountability Act) guidelines Only the investigator will know the Username and Password required to access the research data Data with subject identifiers will not be released
What Is Data Storage amp Confidentiality
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
When How And Whom To Ask For Help
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
For Example Study DesignhellipMethods
Sometimes Yoursquore the Expert
bull Use existing study methods as a template
bull ldquoTweakrdquo design and procedures to fit your unit
bull Do a ldquowalk throughrdquo to identify procedure glitches
Sometimes Yoursquore Not
bull Sample size estimation
bull Research design
bull Validity and reliability of instruments
bull Informed consent ndash construction and loopholes
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
bull Validate design choice with an expert ndash Discuss your thoughts with a statistician or an author of
a similar study to validate your choice bull Data analysis is based on the relationships between your
variables ndash It is important to design data collection to reflect the correct or
desired relationship between variables
ndash Enlist the same expert in the beginning that will be helping you analyze the data in the end
bull Be as specific as possible ndash Include enough detail that another researcher would be able to
repeat the study if desired
When Writing Design Section
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml
Duke Translational Nursing Institute
Enlist the Help of Expert
bull DTNI email dtnimcdukeedu
919-668-2344
bull DUSON ORA
919-684-5376
bull DUHS Research Nurse Scientist
919-613 6406
Duke Translational Nursing Institute
Additional Resources
bull wwwcehjournalorg0953-683320jceh_20_61_017html
bull higheredmcgraw-
hillcomsites0073049506student_view0glossaryhtml